阿利沙坦酯对合并高尿酸血症的轻中度原发性高血压的临床疗效研究

Clinical study on the effects of allisartan isoproxil in the treatment of mild to moderate essential hypertension with hyperuricemia

目的 评估阿利沙坦酯在真实临床诊疗环境中对合并高尿酸血症的轻中度原发性高血压的降压疗效及对尿酸的影响。方法 在全国44家研究中心,选择2016年9月至2018年12月符合纳入标准的轻中度原发性高血压合并高尿酸血症患者,每日给予阿利沙坦酯片240 mg,用药4周后评估血压是否达标,达标者(即收缩压<140 mmHg和舒张压<90 mmHg,1 mmHg=0.133kPa)继续用药8周,未达标者1∶1随机分配到阿利沙坦酯片240 mg+吲达帕胺缓释片1.5mg组(简称A+D组)或阿利沙坦酯片+苯磺酸氨氯地平片5 mg组(简称A+C组)治疗8周。比较不同治疗组血压和血尿酸的变化。结果 共486例原发性高血压伴高尿酸血症患者,其中单药治疗326例,A+D组83例,A+C组77例。全部患者年龄(52.81±11.27)岁,体质指数为25.84±2.61,基线血压(149.66±10.28)/(92.85±8.26)mmHg,基线尿酸水平(459.41±72.76)μmol/L。治疗12周后,总体血压达标率73.20%。单药治疗不达标患者血压达标率分别达到55.13%(A+D)和49.32%(A+C),组间比较差异无统计学意义。共155例患者血尿酸水平恢复至正常范围,占34.14%,其中单药治疗组114例(34.97%),A+D组10例(12.05%),A+C组31例(40.26%)。A+D组治疗后血尿酸水平轻度增高(468.62比497.72μmol/L,P=0.0167),A+C组血尿酸水平降低(477.52比432.52μmol/L,P=0.0003),差异均有统计学意义。结论 合并高尿酸血症轻、中度原发性高血压患者采用以阿利沙坦酯为基础的降压治疗方案,在有效控制血压的基础上能够有效降低患者血尿酸水平,联合应用钙拮抗剂效果更佳。

Objective To evaluate the antihypertensive effects of allisartan isoproxil on mild to moderate essential hypertension complicated with hyperuricemia and its effect on plasma uric acid in a real clinical environment. Method Patients with mild to moderate essential hypertension complicated with hyperuricemia were who met the inclusion criteria in 44research centers in China from Sep. 2016 to Dec. 2018 were enrolled Allisartan isoproxil tablet 240 mg per day was administered for 4 weeks,then the same treatment continued for 8 weeks if blood pressure(BP)achieved the target of SBP/DBP<140/90 mm Hg;the non-achievers were 1∶1 randomly divided into two groups,one was giren allisartan isoproxil 240mg+indapamide sustained-release tablet 1.5 mg(A+D),and the other was giren allisartan isoproxil 240 mg+amlodipine besylate 5 mg(A + C)for 8 weeks. Then compare the changes in blood pressure and plasma uric acid after different treatments. Results Totaly 486 patients were enrolled. of whom there were 326 patients receiving single drug treatment and there were 83 patients in A+D group and 77 were in A+C group. The average age was(52.81 ± 11.27)years old,BMI was25.84 ± 2.61,the baseline BP was(149.66 ± 10.28)/(92.85 ± 8.26)mmHg,the baseline uric acid was(459.41±72.76)μmol/L. After 12 weeks of treatment,the total BP targeting rate was 73.20%. The BP targeting rate in non-achievers of monotherapy was 55.13%(A+D)and 49.32%(A+C)respectively. There was no sstatistical drfference between the groups.The plasma uric acid returned to normal range in 155patients(34.14%),among whom 114(34.97%)were in allisartan monotherapy group,10(12.05%)in A+D group and 31(40.26%)in A+C group. The plasma uric acid slightly increased in A+D group(468.62 vs. 497.72 μmol/L,P=0.0167)and decreased in A+C group(477.52 vs.432.52 μmol/L),both differences were statistically significant(P=0.0003). Conclusion The therapeutic regimen based on allisartan isoproxil is effect in patients with mild to moderate essential hypertension complicated with hyperuricemia. It can decrease the plasma uric acid level on the basis of effectively controlling blood pressure,and it is more effectire when combined with calcium channel blockers.